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General MedicationsORALGeneric

FAZACLO ODT

CLOZAPINE

Standard Dose
200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons**
Max Dose
Refer to approved labeling
Primary Use
Review priority: 901 REQUIRED Marketing status: Discontinued
Summary

Approval overview FAZACLO ODT is listed in Drugs@FDA under application 021590 (NDA).

Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient CLOZAPINE Form and strength TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor JAZZ Submission history Latest submission status date: 2020-04-14 00:00:00.

Structured Monograph

Clinical summary

Approval overview FAZACLO ODT is listed in Drugs@FDA under application 021590 (NDA). Review priority: 901 REQUIRED Marketing status: Discontinued Active ingredient CLOZAPINE Form and strength TABLET, ORALLY DISINTEGRATING;ORAL - 200MG **Federal Register determination that product was not discontinued or withdrawn for safety or effectiveness reasons** Sponsor JAZZ Submission history Latest submission status date: 2020-04-14 00:00:00. Submission type: SUPPL.

Monitoring

  • • Marketing status: Discontinued
  • • Review priority: 901 REQUIRED

Interaction Notes

  • No interaction notes stored yet.